The Committee deems that the clinical benefit of OLUMIANT 2 mg and 4 mg (baricitinib), film-coated tablet, remains low for the treatment of atopic dermatitis in adults requiring systemic treatment, in cases of failure to respond, intolerance or contraindication to ciclosporin.
Clinical Added Value
no clinical added value
Within the reimbursement scope selected by the Committee:
In view of:
the very modest effects observed with baricitinib versus placebo, in all of the phase III studies (as monotherapy or in association with dermocorticosteroids, in particular in patients failing to respond to ciclosporin) and on all of the outcome measures;
the lack of evidence of a benefit on quality of life in a condition that particularly affects quality of life with substantial psychosocial repercussions;
the lack of comparison to ciclosporin, the conventional first-line systemic treatment in atopic dermatitis;
the lack of comparison to dupilumab after failure to respond to ciclosporin, even though it was feasible;
a safety profile of baricitinib in the studies on atopic dermatitis primarily marked by infections (rhinopharyngitis or upper respiratory tract infections predominantly, herpes simplex) and headaches;
the risks of major cardiovascular events, malignant tumours, serious infections and all-cause mortality linked with JAK inhibitor class medicinal products requiring restrictions of their use in some patients and persisting uncertainties relating to the populations not studied in the ORAL Surveillance safety study, in particular patients aged under 65 years (average age of approximately 35 years in studies on atopic dermatitis);
the Committee deems that OLUMIANT 2 mg and 4 mg (baricitinib), film-coated tablet, provides no clinical added value (CAV V) in the therapeutic strategy of moderate to severe atopic dermatitis in adults requiring systemic treatment, in cases of failure to respond, intolerance or contraindication to ciclosporin.
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